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PULMATRIX Corporate Overview I NASDAQ:
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"Company"), is set forth in the Company's filings with the Securities and Exchange Commission ("SEC"), including the Company's most recently filed Annual Report on Form 10-K. Investors and security holders are
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forward-looking statement, whether as a result of new information, future events, or otherwise. This presentation contains statistical and market data that we obtained from industry publications, reports generated by third parties, third-party
studies and public filings. Although we believe that the publications, reports, studies and filings are reliable as of the date of this presentation, we have not independently verified such statistical or market data. CAUTION: We have not received
approval from the FDA, or any other regulatory entity, to market our therapeutic candidates in the United States or in any other jurisdictions. Our therapeutic candidates, including Pulmazole, PUR1800, and PUR0200 are classified by the FDA as
investigational drugs and are limited by Federal (or United States) law to investigational use only and will require additional studies to make definitive conclusions and claims about such candidates' safety or efficacy.
Pulmatrix's proprietary iSPERSE
platform, with an initial focus on respiratory disease, optimizes pharmacokinetics and pharmacology to develop, commercialize and deliver transformational medicines to patients globally Transforming Therapies Through iSPERSETM Enabled Drug Delivery
Source: D Singh et al., Br J Clin Pharmacol. 2018, 84(9):2097-2105; Source: ACAAI - 2018 - A Phase 1/1B Study of an Inhaled Formulation of Itraconazole in Healthy Volunteers and Asthmatics; Study Poster Presented at ACAAI in 2018,
www.pulmatrix.com Pulmazole Phase 2 Program in ABPA iSPERSE Strategic Partnerships PUR1800 Phase 1b Program in AECOPD
Phase 2 ABPA and Phase 1b AECOPD
programs with potential combined peak U.S. revenue potential exceeding $3.5B* Expanding global opportunity with Cipla partnership on Pulmazole lead program Proprietary iSPERSE technology to optimize pharmacokinetics and pharmacology in respiratory
and non-respiratory therapeutics A scalable platform with application across drug classes and dry-powder delivery devices creates broad potential for strategic partnerships Intellectual property portfolio well into 2030's Investment Highlights
4 * Source: Physician Interviews and Payer Interviews; ClearView Health Partners Analysis.
Experienced Leadership Team With
Experience to Execute and Deliver Value Mark Iwicki Chairman Terry McGuire Director Strong Background in Product Development & Commercialization Management Bill Duke CFO Ted Raad CEO & Director Dr. Rusty Clayton Head of Clinical Development
Michael Lipp, PhD Chemistry Manufacturing & Controls Strategy Diverse Collective Experience from Leading Respiratory Companies Board of Directors Matthew Sherman Director Michael Higgins Director Amit Munshi Director Steve Gillis, PhD
Product Pipeline Indication 2019 2020
Pulmazole Anti-fungal Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma PUR1800 NSKI Acute Exacerbations of COPD (AECOPD) PUR5700 NSKI Idiopathic Pulmonary Fibrosis (IPF) Robust Pipeline with Projected Significant Value
Catalysts* * Estimated Milestones Global Pulmazole partnership and revenue share with Cipla Technologies R&D collaboration discussions underway regarding PUR5700 Additional 505(b)2 iSPERSE enabled pipeline opportunities under consideration
Multiple parties engaged in potential iSPERSE technology driven partnerships iSPERSE Partner funded R&D collaborations leveraging iSPERSE to enable new therapies and create opportunities for partnership CMC Pre-Clinical Ph2 Ph2 Data Anticipated
Ph1b Ph1b Data Anticipated 01 02 03 04
iSPERSE Small Dense and Dispersible
iSPERSE Enables Product Development Not
Possible With Conventional Technologies Small molecules, biologics and macromolecules with challenging physical and chemical attributes Targeted delivery to provide efficacious doses Control of pulmonary and systemic exposure IMPROVING DELIVERY
IMPROVING DOSING IMPROVING SAFETY PROFILES Sources: D Singh et al., Br J Clin Pharmacol. 2018, 84(9):2097-2105;; Perry, J, et al., Br J Clin Pharmacol. 2019, 85(3):580-589; ACAAI - 2018 - A Phase 1/1B Study of an Inhaled
Formulation of Itraconazole in Healthy Volunteers and Asthmatics; Study Poster Presented at ACAAI in 2018, www.pulmatrix.com
Potential iSPERSE Advantages Evolution
of Engineered Dry Powder Drug Delivery iSPERSE Platform Can be used with a broad range of drugs, small molecule to biologic Can be used with any device (e.g. metered-dose, reservoir, capsule or blister-based inhalers) Requires low inspiratory flow
for penetration deep into lung, based on high dispersibility Can deliver large doses into lungs (tens of milligrams) with high delivery efficiency Avoids first-pass effect and systemic side-effects with improved pharmacokinetics profile compared to
oral delivery Broad IP portfolio into 2030s iSPERSE Large Porous Particle (ARCUS ) Small Porous Particle (PulmoSphereTM) 1 m iSPERSE enables sick patients to get more effective doses Small, dense & dispersible particles designed for
highly efficient respiratory delivery Sources: D Singh et al., Br J Clin Pharmacol. 2018, 84(9):2097-2105;; Perry, J, et al., Br J Clin Pharmacol. 2019, 85(3):580-589; ACAAI - 2018 - A Phase 1/1B Study of an Inhaled
Formulation of Itraconazole in Healthy Volunteers and Asthmatics; Study Poster Presented at ACAAI in 2018, www.pulmatrix.com
Pulmazole Inhaled Antifungal Inhaled
Itraconazole to Treat Allergic Bronchopulmonary Aspergillosis (ABPA) in Patients with Asthma
Allergic Bronchopulmonary
Aspergillosis (ABPA) in Patients with Asthma Shah. Allergy Asthma Immunol Res. 2016;8(4):282; Tracy, J Fungi 2016;2:17; Agarwal, Clinical & Experimental Allergy. 2013;43, 850-873; Patterson. Proc Am Thorac Soc. 2010;7:237; Physician Research:
Clearview Analysis; Estimate of Adult ABPA Prevalence Based on Country-specific Studies. ~1.5% of adult patients with asthma (~300K U.S. / ~5MM Global) suffer from ABPA. ABPA causes airway inflammation, leading to lung damage and fibrosis. Treatment
focus Control of asthma symptoms Prevention and treatment of pulmonary exacerbations Reduction of pulmonary inflammation to prevent end-stage fibrotic disease Treatments are limited to steroid and oral antifungal therapies Typical first line
treatment is oral steroid therapy, followed by combination with oral antifungals, after insufficient treatment response with oral steroids Healthy Lung Diseased Lung Exaggerated response of the immune system to the fungus Aspergillus in patients
with asthma and cystic fibrosis Untreated ABPA may result in pulmonary fibrosis, respiratory failure and potentially death.
Dose Limiting Side Effects of Oral
Antifungal Therapy Reduce Clinical Utility Significant Unmet Need Exists in ABPA Wang. AMAC. 2010;54:2409. Denning. Clinical Infectious Diseases. 2002;34:563; Lestner. Clinical Infectious Diseases 2009; 49:928-30; Denning. Clinical and
Experimental Dermatology. 2001;26:648; Greenberger P., B.R., Demain J, et. al., Allergic Bronchopulmonary Aspergillosis. J Allergy Clin Immunol Pract., 2015. 2(6): p. 703-708.; Physician Research: Clearview Analysis Gastro Intestinal Intolerance
Hepatic Abnormality Cutaneous Reactions Variable and Poor PK Drug to Drug Interactions Fatigue Visual Changes Significant Unmet Need Remains with Current Treatment Options in ABPA ~50% of ABPA patients have inadequate response to oral steroids alone
~20% of ABPA patients become steroid dependent Long-term steroid use associated with development of complications including invasive aspergillosis Antifungal agents are believed to reduce fungal burden (antigen induces inflammatory response)
Antifungal treatment improves clinical outcomes and can potentially enable a reduction in steroid burden While the majority of antifungal use in ABPA is itraconazole, overall antifungal use is limited by safety/tolerability concerns
Ph1/1b Data Highlights Potential to
Improve Upon Oral Sporanox Known FEV1, Safety and Tolerability Profile Phase 1/1b : Safety, Tolerability & PK Study in Healthy Normal Volunteers and Patients with Asthma Part 1: Single Ascending Dose (SAD) Healthy Normal Volunteers (n=6/cohort):
Optional 4th cohort of 35 mg Part 2: Multiple Ascending Dose (MAD) Healthy Normal Volunteers (n=5-6/cohort) Part 3: Single Dose Crossover Patients with Asthma (n=16) Pulmazole (5 mg) Pulmazole (10 mg) Pulmazole (25 mg) Pulmazole (35 mg) Pulmazole
(10 mg) Pulmazole (20 mg) Pulmazole (35 mg) Sporanox (200 mg; oral) Pulmazole (20 mg) Sporanox (200 mg; oral) Pulmazole (20 mg) STUDY OBJECTIVES Parts 1 and 2 SAD and MAD in HNV Safety and tolerability of Pulmazole administered up to 14
days Part 3 Single Dose Crossover in Stable Patients with Asthma Safety and tolerability of Pulmazole administered as a single dose in patients with asthma Through measurement of itraconazole levels in sputum and plasma, compare lung exposure and
plasma exposure of single dose Pulmazole 20mg vs. single dose oral Sporanox 200mg 13
Pulmazole: Potential to Change
Standard of Care for ABPA Ph1/1b study successfully met all endpoints Source: ACAAI - 2018 - A Phase 1/1B Study of an Inhaled Formulation of Itraconazole in Healthy Volunteers and Asthmatics; Study Poster Presented at ACAAI in 2018,
www.pulmatrix.com Phase 1/1b Part 1 & 2: SAD and MAD Key Results Phase 1/1b Part 3: Single Dose Crossover Pulmazole 20mg Versus Single Dose Sporanox 200mg Oral 85 50 ~ fold higher lung exposure ~ 1/10th fold lower plasma exposure of dose
Demonstrated safety and tolerability of Pulmazole administered up to 14 days Plasma exposure over 24 hours than expected with oral Sporanox 100 - 400 ~ Fold lower 14
Pulmazole Development Plan Builds
Upon Clinical Precedent of Sporanox Improvement of FEV1 in ABPA 2018, Agarwal et al. In acute stage treatment naive ABPA patients, monotherapy itraconazole is effective in considerable number of patients, including improved FEV1 within 6 weeks, with
less side-effects compared to prednisolone monotherapy 2000, Stevens et al. Itraconazole improved FEV1 and decreased steroid use and total IgE in a randomized double-blind trial with 55 patients 2003, Wark et al. Itraconazole improved FEV1 ,
decreased total IgE and the exacerbation frequency in a randomized, double-blind trial with 29 patients Source: Stevens. NEJM.2000;342(11):757; Wark. J Allergy Clin Immuno. 2003;111; 952; Agarwal Chest 2018; doi: 10.1016/j.chest.2018.01.005 Three
clinical studies demonstrated that Sporanox treatment in addition to standard of care improved both disease biomarkers and FEV1 Stevens and Wark studies support inclusion of oral Sporanox into current ABPA treatment guidelines (2016 IDSA) and were
drivers behind the Pulmazole Ph2 and Ph2b/3 study designs Stevens, Wark and Agarwal studies showed significant improvement in FEV1 and biomarkers for ABPA Pulmazole is expected to improve upon the known efficacy, safety and tolerability profile of
oral Sporanox given the Ph1/1b results of ~50 fold higher lung exposure and ~85 fold lower plasma exposure than oral Sporanox at 1/10 the dose Pulmazole is anticipated to improve upon Sporanox outcomes demonstrated in clinical literature 01 02 03
1/10th of dose 28-day safety,
tolerability, pulmonary function and biomarker study in patients with asthma and ABPA Phase 2 Study Underway is Expected to Support Proof of Mechanism in Patients with Asthma-ABPA Randomized, double-blind, placebo controlled study (1:1
randomization; n = 16 per arm) Primary Endpoint Safety & tolerability Pulmonary function (FEV1) Biomarkers Other Endpoints Plasma and sputum PK FEV1 Sputum and plasma eosinophils Serum IgE IgE and IgG (specific to A. fumigatus antigens) plasma
concentrations Aspergillus burden in sputum Disease control (ACQ-6) FeNO 3Q-2019 4Q-2019 1Q-2020 2Q-2020 3Q-2020 Phase 2 Start Phase 2 Data Anticipated Upcoming milestones Patient Profile Patients with Asthma (M/F, ages 18-65) with confirmed/stable
Asthma and ABPA ABPA Patients Placebo Pulmazole (10 mg) Pulmazole (20 mg) Pulmazole (35 mg) Endpoints Safety Tolerability Pulmonary Function Biomarkers 16
1/10th of dose Potential Ph3 study
design pending Ph2 results and FDA feedback Phase 3 Trial Powered to Show FEV1 Improvement Randomized, double-blind, placebo controlled study (n=120 per arm). 16 weeks dosing with 16 weeks follow-up. Primary Endpoint FEV1 Secondary Endpoints Disease
control (ACQ-6) Combined Asthma and ABPA exacerbations (frequency/timing) Steroid use Biomarkers Sputum/plasma eosinophils Serum IgE IgE and IgG (specific to A. fumigatus antigens) plasma concentrations Aspergillus burden in sputum FeNO ABPA
Patients Placebo Pulmazole (10 mg)* Pulmazole (20 mg)* Endpoints FEV1 Exacerbations PFT/Biomarkers Disease Control QOL Patient Profile Patients with moderate-to-severe asthma (M/F, ages 18-65) confirmed/stable Asthma and ABPA * Final Ph3 doses to be
determined following Ph2 and 6-month non-clinical toxicology *Final dose selection to be determined 17
Pulmazole: $1.5B Peak Net Revenue
Potential in the U.S. Anticipated 1st line use drives Pulmazole's ~$1.5B U.S. peak net revenue forecast Source: Physician Interviews; Payer Interviews; ClearView Analysis. *Also includes discount for patient compliance, patient persistence,
and gross-to-net adjustment and peak revenues expected at loss of market exclusivity, ~11 years post launch; ** Estimate based on ClearView Analysis, which took into account uninsured patients, patients who are unwilling to pay, and projected access
restrictions placed by payers ~$200M U.S. Other Indications ~$1.3B U.S. ABPA Asthma Net Revenue 1st Line Antifungal Usage May More than Double Xolair is indicated for severe asthma poorly controlled by ICS with a reactivity to aeroallergen Nucala is
indicated for patients with severe asthma and an eosinophilic phenotype Cinqair is indicated for patients with severe asthma and an eosinophilic phenotype Payers Interviewed Suggested ~80% Market Access*** and ~$40K Annual Treatment Cost Similar to
TOBI Podhaler and Severe Asthma Biologics Xolair Annual Price: ~$40 K Tobi Podhaler Annual Price: ~$40K TOBI Podhaler is a dry powder inhaled antibiotic for cystic fibrosis patients with Pseudomonas aeruginosa Nucala Annual Price: ~$35 K
Cinqair Annual Price: ~$25K
Cipla Partnership: Expanding Global
Opportunities Partnership validates Pulmazole development plan and potential of iSPERSE technology platform Partnership $22M up-front payment, combined with funds raised by Pulmatrix, fully funds the company beyond the Pulmazole Ph2 study data Cipla
Technologies, a Cipla wholly owned subsidiary, was incorporated in 2018 to develop and commercialize branded products with a respiratory and neurology focus Equal sharing of future Pulmazole development and commercialization costs and worldwide free
cash flows (profit) Cipla is India's 2nd largest pharmaceutical company with global presence in over 130 countries, over 35 manufacturing facilities and a vast network for direct commercialization and strategic alliances Cipla Technologies
Clinical precedent supports oral
Sporanox efficacy in asthma-ABPA, including FEV1 and exacerbation improvement Ph1/1b data demonstrated potential for Pulmazole to improve upon the known efficacy, safety and tolerability of oral Sporanox Improved efficacy, safety and tolerability
has the potential to increase antifungal use and shift Pulmazole to first line treatment for ABPA - addressing the underlying cause of disease and avoiding side effects of oral antifungal therapy and prolonged steroid treatment Ph2 proof of
mechanism clinical study readout planned mid-2020 Worldwide 50-50 co-development and revenue share Pulmazole partnership with Cipla Technologies on a potential ~$1.5B peak net revenue opportunity in U.S. alone Potential to Expand and Shift Inhaled
Antifungal Use to First Line Treatment in ABPA Pulmazole Highlights 20 * Research: Clearview Analysis
PUR1800 Narrow Spectrum Kinase